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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S4; LARYNGOSCOPE, RIGID
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VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 0574-0195
Device Problems Display or Visual Feedback Problem (1184); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been received by verathon, however; at the time of the report the device has not been evaluated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
 
Event Description
The customer reported that during a patient procedure, using a glidescope spectrum lopro s4, the light went off when the spectrum lopro s4 was severely bent.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
 
Manufacturer Narrative
The glidescope spectrum lopro s4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope spectrum lopro s4 and was able to reproduce the reported issue by hand.When tested on a training manikin the verathon technical service representative was unable to reproduce the reported issue.The glidescope spectrum lopro s4 has been sent over to verathon medical ulc office located in burnaby, ca for further investigation.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
 
Manufacturer Narrative
The glidescope spectrum lopro s4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope spectrum lopro s4 and was able to reproduce the reported issue by hand.When tested on a training manikin the verathon technical service representative was unable to reproduce the reported issue.The glidescope spectrum lopro s4 was forwarded over to verathon medical ulc office located in burnaby, ca for further investigation.A verathon engineer representative in verathon medical ulc office in burnaby, ca evaluated the glidescope spectrum lopro s4, but was unable to reproduce the reported issue initially.When connecting the glidescope spectrum lopro s4 to a known, good, test glidescope go monitor the image was normal when the hdmi connection was fully seated.The verathon engineer representative then slightly disconnected the hdmi connection between the glidescope spectrum lopro s4 female hdmi connector to the test glidescope go monitor male hdmi connector and applied force to the tip of the lopro s4 by hand.With the applied force the led intermittently went off and the image on the glidescope go monitor darkened.The verathon engineer representative measured the glidescope spectrum lopro s4 hdmi connector for any variation but confirmed it met verathon current specifications for this device.Upon completion of the evaluation the glidescope spectrum lopro s4 was scrapped due to it being a single-use device and was sent in to be evaluated only.At this time, the cause of the reported issue could not be fully determined; however, it is likely that manipulating the spectrum lopro s4 caused a partial disconnection from the glidescope go monitor at the hdmi connector.This may have caused or contributed to the reported issue.Corrective action is not required at this time.Verathon will continue to monitor for trends.
 
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Brand Name
GLIDESCOPE SPECTRUM LOPRO S4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
VERATHON MEDICAL ULC
2227 douglas road
burnaby, british columbia V5C 5 A9
CA  V5C 5A9
Manufacturer (Section G)
VERATHON MEDICAL ULC
2227 douglas road
burnaby, british columbia V5C 5 A9
CA   V5C 5A9
Manufacturer Contact
corey kasbohm
20001 n creek pkwy
bothell, WA 98011-8218
4256295760
MDR Report Key12896600
MDR Text Key282813182
Report Number9615393-2021-00357
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0574-0195
Device Catalogue Number0270-0939
Device Lot NumberJF10409961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2021
Initial Date FDA Received11/30/2021
Supplement Dates Manufacturer Received12/20/2021
12/20/2021
Supplement Dates FDA Received12/28/2021
02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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